Forms and Documents

Genentech BioOncology® Access Solutions for COTELLIC and ZELBORAF Enrollment Forms

The Prescriber Service Form and PAN are required for enrollment in Genentech BioOncology Access Solutions. The Prescriber Service Form replaces the Statement of Medical Necessity (SMN).

 

Other Important Documents

Considerations for Composing a Letter of Medical Necessity

This guide provides tips to help you draft a letter of medical necessity. A sample letter is also included for your reference. Use the links below to find additional information to enclose in your letter.

FDA approval letter (Follow this link and search by the drug name)

Prescribing Information

Sample coding for COTELLIC AND ZELBORAF

 

Considerations for Composing a Sample Appeal Letter

This guide provides tips to help you draft an appeal letter. A sample letter is also included for your reference. Use the links below to find additional information to enclose in your letter.

FDA approval letter (Follow this link and search by the drug name)

Prescribing Information

Sample coding for COTELLIC AND ZELBORAF

 

Enrolling in the Genentech Patient Foundation

The Genentech Patient Foundation gives free medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.

 

Fax Cover Letter

Use this cover sheet when faxing documents to Genentech BioOncology Access Solutions for COTELLIC and ZELBORAF.

PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.

Important Safety Information & Indication

Indications and Usage

COTELLIC (cobimetinib) is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with ZELBORAF (vemurafenib).

Important Safety Information

WARNINGS AND PRECAUTIONS

Review the Full Prescribing Information for ZELBORAF for information on the serious risks of ZELBORAF.

The following can occur in patients treated with COTELLIC:

  • New primary malignancies, including cutaneous and non-cutaneous malignancies
  • Hemorrhage, including major hemorrhages
  • Cardiomyopathy, defined as symptomatic and asymptomatic decline in left ventricular ejection fraction
  • Severe dermatologic reactions, including rash and other skin reactions
  • Serous retinopathy and retinal vein occlusion
  • Hepatotoxicity
  • Rhabdomyolysis
  • Severe photosensitivity
  • Embryo-fetal toxicity

The following can occur in patients treated with ZELBORAF:

  • New primary malignancies including cutaneous squamous cell carcinoma, non-cutaneous squamous cell carcinoma, new primary melanoma, and other malignancies
  • Tumor promotion in BRAF wild-type melanomas
  • Serious hypersensitivity reactions including anaphylaxis
  • Severe dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
  • QT prolongation
  • Hepatotoxicity including liver injury leading to functional hepatic impairment (including coagulopathy or other organ dysfunction); increases in transaminases and bilirubin when concurrently administered with ipilimumab
  • Photosensitivity
  • Ophthalmologic reactions, including uveitis, blurry vision, and photophobia
  • Embryo-fetal toxicity
  • Radiation sensitization and radiation recall, including fatal cases in patients with visceral involvement
  • Renal failure, including acute interstitial nephritis and acute tubular necrosis
  • Dupuytren’s contracture and plantar fascial fibromatosis

USE IN SPECIFIC POPULATIONS: Lactation

Advise women not to breastfeed during treatment with COTELLIC and ZELBORAF and for 2 weeks after the final dose of COTELLIC or ZELBORAF (whichever is taken later).

DRUG INTERACTIONS

  • Avoid concomitant administration of COTELLIC with strong or moderate CYP3A inducers or inhibitors.
  • Avoid concurrent use of ZELBORAF with strong CYP3A4 inhibitors, strong CYP3A4 inducers, and CYP1A2 and P-glycoprotein substrates with narrow therapeutic windows.

Most Common Adverse Reactions

The most common (≥20%) adverse reactions with COTELLIC were diarrhea (60%), photosensitivity reaction (46%), nausea (41%), pyrexia (28%), and vomiting (24%). The most common (≥5%) Grade 3-4 laboratory abnormalities were increased GGT (21%), increased CPK (14%), hypophosphatemia (12%), increased ALT (11%), lymphopenia (10%), increased AST (8%), increased alkaline phosphatase (7%), and hyponatremia (6%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see both Full COTELLIC Prescribing Information and Full ZELBORAF Prescribing Information for additional Important Safety Information.